NAFLDOMICS in MASLDNCT06982378
GLP-1 RA on Liver OMICS in MASLD
An observational study of NAFLD and Diabetes, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- GLP-1 receptor agonist
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 9 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: known diagnosis of MASLD by histology, also have diabetes/ obesity
Who may be able to join
- known diagnosis of MASLD by histology, also have diabetes/ obesity
- on treatment with GLP-1 RA at stable dose
Who cannot join
- unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
- on immunosuppression, liver or kidney transplant
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD
In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated.
In this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.
Read the detailed description
The study involves patients with a diagnosis of MASLD by histology and have diabetes/obesity. The 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of GLP-1 treatment with those who did not have GLP-1 agents.
The study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of GLP-1 agents in these patients
- Being tested
- GLP-1 receptor agonist
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
on and not on treatment
| Study group | Role | What they receive |
|---|---|---|
| Without GLP-1 RA treatment | Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA | |
| Had GLP-1 RA treatment | Patients with MASLD and obesity/diabetes - on GLP-1 RA as a standard of care treatment Receives: Drug: GLP-1 receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipidomics profile on use of GLP-1 RA
Lipidomic profile being evaluated
Measured: 1 year
Secondary outcomes (1)
Changes in associated proteomics and transcriptomics with the use of GLP-1 RA
proteomic and transcriptomics profiles evaluated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jul 2026
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Why it stopped: no grant approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achuthan Sourianarayanane, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982378
- Sponsor's protocol ID
- PRO00050604
- Acronym
- OMICS in MASLD
- Status last verified
- Jul 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD
- ClinicalTrials.gov ID
- NCT06982378
- Acronym / sponsor ID
- OMICS in MASLD / PRO00050604
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no grant approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated.
In this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.
Detailed description
The study involves patients with a diagnosis of MASLD by histology and have diabetes/obesity. The 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of GLP-1 treatment with those who did not have GLP-1 agents.
The study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of GLP-1 agents in these patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without GLP-1 RA treatment | – | –Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA |
| Had GLP-1 RA treatment | – | Drug: GLP-1 receptor agonistPatients with MASLD and obesity/diabetes - on GLP-1 RA as a standard of care treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- known diagnosis of MASLD by histology, also have diabetes/ obesity
Key inclusion criteria (2 listed)
- known diagnosis of MASLD by histology, also have diabetes/ obesity
- on treatment with GLP-1 RA at stable dose
Key exclusion criteria (3 listed)
- unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
- on immunosuppression, liver or kidney transplant
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agoniston and not on treatment | Drug | Had GLP-1 RA treatment |
Primary outcome
Changes in lipidomics profile on use of GLP-1 RA
Time frame: 1 year
Lipidomic profile being evaluated
1 secondary outcome
Changes in associated proteomics and transcriptomics with the use of GLP-1 RA
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Recruiting
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RecruitingPhase 1
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RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD and Diabetes, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipidomics profile on use of GLP-1 RA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.